Assessment of safty and efficacy of ADR-001, adipose tissue-derived stem cells for patients with idiopathic pulmonary fibrosis

JRCT ID: jRCT2063200007

Registered date:22/06/2020

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Idopathic pulmonary fibrosis
• Date of first enrollment: 22/06/2020
• Target sample size: 18
• Study type: Interventional

Intervention(s)

After getting consent, assess pre-trial examination, and register the cases who are qualified for this clinical trial.
ADR-001 is given on day 1, and observe safety until day 8 as inpatients.
The treatment of the second case in cohort 1 should start more than 7 days after treatment of the first case from the safty point of view.
DLT should be monitored for 7 days following ADR-001 treatment.
If the safty is confirmed by the assessent of DLT at level 1 or 2 of treatment, next step of level can be used for the treatment dose.

Outcome(s)

• Primary Outcome: Safty: MTD, DLT, adversed effects.
• Secondary Outcome: Efficacy (symptoms, PaO2, Chest CT findings, &MD, respiratory function test, Japanese version of SGRQ-1)

Key inclusion & exclusion criteria

• Age minimum: >= 40age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) no less than 40 years old.
2) informed consent of this study
3) diagnosis of IPF
4) FVC no less than 50% of predicted value
5) %DLCO 30~37%
6) PO2 no less than 55mmHg
7) Patiens with treatment history of anti-fibrotic treatment but who discontined because of its side effects or getting no enough efficacy.

Exclude criteria

1)Obstructive pulmonary dysfunction:FEV1/FVC<0.7
2)Patiens who need exygen therapy15 hours a day or more.
3)History of acute exacerbation within 6 weeks of getting consent or examination 2
4)Habing infection which need to be treated at getting consent or at examination 2
5)HB, HCV, HIV, or HTLV-1 antibody positive at examination 1
6)History of organ, bone marrow or other cell transplantation, or cell therapy
7)Possibiity of getting lung transplantation during clinical trial period
8)Mortality less than 2.5 years due to other diseases than IPF
9)Treatment with anti-fibrotic drugs (nintedanib, pirfenidone), tacrolimus, cyclophosphamide, or mycophenolate mofetil wihin 8 weeks of getting consent
10)Treatment with other Investigational new drugs within 4 weeks of getting consent
11)Treatment with more than 10 mg of predonizolone within 8 weeks of getting consent. Dose change of predonizolone within 8 weeks of getting consent even if the dose is less than 10 mg/day
12)Severe liver, renal, heart diseases, severe organ failure, or severe complications as follows:
T-bil 1.5 times more than value more than normal limit.
Cr value more than 2mg
Congestive Heart failure (NYHA:Class III-IV) except for the patients who have dyspnea due to IPF.
Active conorary artery diseases
Uncontrolled hypertention
Arrhythmia: Grade 2 or more in TCAE ver 5.0
13)Getiing treatment of malignancy, history of malignancy treatment within 5 years, except for cervical intraepithelial carcinoma and gastric mucosal cancer following comlete recection, and basal cell carcinoma and squamous cell carcinoma of the skin following appropriate treatment
14)During pregnancy or lactating. Fertile female patients who do not prevent pregnancy during a month from the point of time of examination 1.
15) Male fertile patients who do not use a condom during clinical trial period
16)Abuce of alchohol or substance
17)Difficulty of getting consent due to mental illness
18)Allergy for penicillin, aminoglycosidee antibiotics, or dimethylsulfoxide
19)patients who are judged as unqualified cases by the doctors involved in he clinical trial

Related Information

• Primary Sponsor: Miyahara Nobuaki
• Secondary Sponsor: ROHTO Pharmaceutical Co., Ltd